Duration of Music Interventions and Pain Tolerance (DOMINANT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-28

Study Completion Date

2024-11-15

Brief Summary

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This study will investigate the effect of different durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance.

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Detailed Description

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Music interventions reduce perioperative pain and anxiety. However, it is yet unclear how long music needs to be presented in order to have an effect. Therefore, the investigators would like to propose a pilot randomized controlled trial in order to investigate the optimal duration of musical interventions. The main objective of this study is to investigate the effect of different durations of music interventions on pain tolerance (expressed in amperage). Secondary objectives are to investigate the effects of music duration on heart rate variability (expressed in milliseconds) and subjective measurements of emotions, anxiety and pain. Healthy volunteers (age ≥18 years) will be included, and the study will take place at the outpatient clinic of the Center of Pain Medicine, Erasmus Medical Center, Rotterdam.

Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The randomized controlled trial will have four study arms. Subjects will be assigned to one of the four arms: control without music and music groups with 1 minute, 5 minutes and 20 minutes. All subjects will receive electric stimuli in three phases. In each phase, subject will be exposed to three consecutive stimuli. First a detection threshold will be measured. Secondly a baseline test will be performed in order to assess basic levels of pain endurance. Hereafter, the intervention phase starts. Subjects in the music groups will listen to 1, 5 and 20 minutes of their own preferred music through headphones. Directly after, all subjects will again receive three electric stimuli.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Due to the nature of the study and the music intervention, it is not possible to blind participants and investigators. However, participants will not be informed of the study arm to which they are randomized in advance.

Study Groups

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Control group

The control group will be seated for 20 minutes without doing anything else, and not listen to music.

Group Type ACTIVE_COMPARATOR

Not listening to music

Intervention Type OTHER

Participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones), for a duration of 20 minutes.

1 minute music group

The 1 minute music group will be seated for 19 minutes without doing anything else, and listen to music for 1 minute.

Group Type EXPERIMENTAL

Listening to music for 1 minute

Intervention Type OTHER

Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 1 minute through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels. The 19 minutes before the 1 minute music listening intervention, participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones).

5 minutes music group

The 5 minutes music group will be seated for 15 minutes without doing anything else, and listen to music for 5 minutes.

Group Type EXPERIMENTAL

Listening to music for 5 minutes

Intervention Type OTHER

Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 1 minute through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels. The 15 minutes before the 5 minutes music listening intervention, participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones).

20 minutes music group

The 20 minutes music group will listen to music for 20 minutes.

Group Type EXPERIMENTAL

Listening to music for 20 minutes

Intervention Type OTHER

Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 20 minutes through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels.

Interventions

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Listening to music for 1 minute

Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 1 minute through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels. The 19 minutes before the 1 minute music listening intervention, participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones).

Intervention Type OTHER

Listening to music for 5 minutes

Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 1 minute through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels. The 15 minutes before the 5 minutes music listening intervention, participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones).

Intervention Type OTHER

Listening to music for 20 minutes

Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 20 minutes through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels.

Intervention Type OTHER

Not listening to music

Participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones), for a duration of 20 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Between 18 and 64 years of age
* Sufficient knowledge of the Dutch language to understand the study documents (in the judgement of the attending physician or researcher)
* Provision of written informed consent by subject

Exclusion Criteria

* Significant hearing impairment
* Current complaints of tinnitus
* Current use of analgesic medication
* Presence of acute or chronic pain
* History of cardiac disease or arrhythmias
* Current treatment by a medical specialist or general practitioner
* Professional musician or singer (practicing in average \>1 hour each day)
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes